510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K132965Substantially Equivalent

Solace Sound Generators

Amplisound Hearing Products & Services, Danielson CT / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132965 is the FDA 510(k) clearance record for SOLACE SOUND GENERATORS, a class II device, cleared for Amplisound Hearing Products & Services on under FDA product code KLW (Masker, Tinnitus). FDA records list one 510(k) clearance for Amplisound Hearing Products & Services. As of , FDA records show no recalls naming K132965.

Clearance record

Decision date
Received
(186 days to decision)
Product code
KLW Masker, Tinnitus
Regulation
21 CFR 874.3400
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Amplisound Hearing Products & Services 594 Putnam Rd., Danielson CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KLW

Trailing 12 months
2 clearances under product code KLW in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KLW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260